26 April 2019 - Positive opinion based on results from largest Phase 3 trial performed to date of a PARP inhibitor in GBRCA mutated advanced breast cancer.

Pfizer today announced that the CHMP of the EMA adopted a positive opinion recommending Talzenna (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorisation in the European Union. The indication the CHMP adopted is for Talzenna as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.

The CHMP’s opinion for Talzenna, which was acquired as part of Pfizer’s acquisition of Medivation, will now be reviewed by the European Commission. The marketing authorisation application was submitted based on results from the EMBRACA trial, the largest Phase 3 trial performed to date of a PARP inhibitor in patients with gBRCA-mutated LA or MBC.

Read Pfizer press release